Thermoformed ophthalmic insert devices

ABSTRACT

The present invention describes single-piece or multi-piece Rigid Inserts that may be included in an Ophthalmic Lenses or may comprise the Ophthalmic Lens, wherein the Rigid Insert may be formed through the processing of thin sheet material by thermoforming. Single piece annular Rigid Inserts may perform the function of providing a template for printed patterns to be included in Ophthalmic Lenses. Single piece full Rigid Inserts may perform the function of polarizing light or filtering light based on the properties of materials used to form the insert. Multi-piece Rigid Inserts may include activation and energization elements. The present invention also includes methods and apparatus for forming the Rigid Inserts.

FIELD OF USE

This invention describes methods, apparatus and devices related tothermoforming of insert pieces for inclusion into other OphthalmicDevices and more specifically, in some embodiments, manners of usingthermoforming aspects in the fabrication of an Ophthalmic Lens with aRigid Insert within which or upon which are components.

BACKGROUND

Traditionally an Ophthalmic Device, such as a contact lens, anintraocular lens, or a punctal plug included a biocompatible device witha corrective, cosmetic, or therapeutic quality. A contact lens, forexample, can provide one or more of vision-correcting functionality,cosmetic enhancement, and therapeutic effects. Each function is providedby a physical characteristic of the lens. A design incorporating arefractive quality into a lens can provide a vision corrective function.A pigment incorporated into the lens can provide a cosmetic enhancement.An active agent incorporated into a lens can provide a therapeuticfunctionality. Such physical characteristics may be accomplished withoutthe lens entering into an energized state.

More recently, active components have been incorporated into a contactlens.

An alternative solution may involve the incorporation of energizingelements within the Ophthalmic Device. The relatively complicatedcomponents to accomplish this effect may derive improved characteristicsby including them in insert devices, which are then included withstandard or similar materials useful in the fabrication of state of theart Ophthalmic Lenses. It may be desirable to improve the process,methods, and resulting devices for realizing inserts of various kinds.It may be anticipated that some of the solutions for energized insertsmay provide novel aspects for non-energized devices and other biomedicaldevices. Accordingly novel methods, devices, and apparatus relating tothe thermoforming of various components in ophthalmic and biomedicaldevices formed with inserts are therefore important.

SUMMARY

The present invention includes innovations relating to the method offorming Ophthalmic Lens with a thermoformed insert device, theOphthalmic Lens comprising a thermoformed insert device, wherein thethermoformed insert device comprises a first insert piece, wherein thefirst insert piece is a thermoformed material of a three-dimensionalshape, and a hydrogel encapsulant around the thermoformed insert device.

In some embodiments, the thermoformed insert device may further comprisean alignment feature. In some embodiments, the thermoformed insertdevice may further comprise an optic zone, wherein the thermoformedmaterial in at least the optic zone has the ability to polarize lightthat traverses the optic zone. Alternatively, the thermoformed insertmay be annular, wherein a circular portion in the center of thethermoformed insert may be removed during the thermoforming process.

The thermoformed insert device may comprise a plurality of layers ofmaterial. A first layer of material may have dielectric properties andencloses a portion of a conductive material located upon a surface ofthe insert piece. The first layer of material may have insulatingproperties and enclose a portion of a conductive material located upon asurface of the insert piece. In some embodiments, a layer of materialmay alter the hydrophobicity of the surface of the insert piece.

Some such embodiments may include a layer of colorant covering a portionof the insert piece, for example, in an iris pattern. A polarizing layermay be located between a second and third layer, which may be adjacentto the first layer, and wherein the second and third layer may orientthe polarizing layer. The polarizing layer may be aligned with respectto the alignment feature located within the body of the first insertpiece. In such embodiments, the Ophthalmic Lens may additionallycomprising a stabilizing feature included in the Ophthalmic Lens device,wherein the stabilizing feature orients the lens device in a predefinedorientation on an eye. The Stabilizing Feature may be tinted or markedto provide a visual orientation cue, wherein the Stabilizing Feature mayindicate to the user how to orient the Ophthalmic Lens on the eye.

In some embodiments, the thermoformed insert device may comprise asecond insert piece, wherein the second insert piece is a thermoformedmaterial of a three-dimensional shape, wherein a cavity is defined in aregion between the first insert piece and the second insert piece. Thethermoformed insert device may further comprise a first alignmentfeature located on the first insert piece and a second alignment featurelocated on the second insert piece. The first alignment feature mayinterlock with the second alignment feature. The thermoformed insertdevice may further comprise a sealing layer between the first insertpiece and second insert piece that seals the first insert piece andsecond insert piece together along at least portions of their surfaces.

In some embodiments, the thermoformed insert device further may comprisea meniscus lens active optic element, wherein the meniscus lens activeoptic element is located between the first insert piece and the secondinsert piece. Alternatively, the thermoformed insert device may includean active agent, wherein the active agent may dissolve into theophthalmic environment when the Ophthalmic Lens is placed on an eye.

DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary thermoforming apparatus according tosome embodiments of the present invention.

FIG. 2 illustrates exemplary processing steps to thermoform a componentconsistent with an active energized Ophthalmic Lens.

FIG. 3 illustrates an exemplary complex insert piece that may bethermoformed according to some embodiments of the present invention.

FIG. 4 illustrates exemplary alignment features and strategies that maybe incorporated into inserts utilizing the principles of thermoforming.

FIG. 5 illustrates an exemplary Rigid Insert embodiment utilizing theprinciples of thermoforming.

FIG. 6 illustrates an exemplary Media Insert embodiment utilizing theprinciples of thermoforming.

FIG. 7 illustrates an exemplary lenslet based embodiment utilizing theprinciples of thermoforming.

FIG. 8 illustrates exemplary functional features and strategies that maybe incorporated in inserts utilizing the principles of thermoforming.

FIG. 9 illustrates an exemplary aligned differential polarizationelement embodiment for Ophthalmic Lenses utilizing the principle ofthermoforming.

FIG. 10 illustrates a processing flow in an exemplary method to formthermoformed components and Ophthalmic Lenses incorporating them.

DETAILED DESCRIPTION OF THE INVENTION

The present invention includes methods and apparatus for manufacturingan Ophthalmic Lens with a Rigid Insert where portions of the insert maybe formed by the method of thermoforming. In addition, the presentinvention includes an Ophthalmic Lens with a Rigid Insert incorporatedinto the Ophthalmic Lens.

According to the present invention, an Ophthalmic Lens may be formedwith an embedded Insert, which in some cases includes an Energy Source,such as an electrochemical cell or battery as the storage means for theenergy. In some embodiments, a Rigid Insert also includes a pattern ofcircuitry, components, and Energy Sources. Various embodiments mayinclude the Rigid Insert locating the pattern of circuitry, components,and Energy Sources around a periphery of an optic zone through which awearer of a lens would see, while other embodiments may include apattern of circuitry, components, and Energy Sources that are smallenough to not adversely affect the sight of a contact lens wearer andtherefore the Rigid Insert can locate them within, or exterior to, anoptical zone. The insert pieces of single-piece and multi-piece RigidInserts may be formed by thermoforming Numerous steps may occur on athin substrate sheet before thermoforming or on an insert piece afterthermoforming that may address the various component functions ofinsert-based Ophthalmic Devices.

In general, according to some embodiments of the present invention, aRigid Insert may be embodied within an Ophthalmic Lens via automationthat may place the insert a desired location relative to a mold partused to fashion the lens. The embodiments that place the variouscomponents into the Ophthalmic Lens may employ one or more steps wherecomponents are sealed and adhered into place or components areencapsulated.

In some embodiments, an Energy Source may be placed in electricalcommunication with a component that can be activated on command anddraws electrical current from the Energy Source included within theOphthalmic Lens. A component may include, for example, a semiconductordevice, an active or passive electrical device, or an electricallyactivated machine, including for example: Microelectromechanical systems(MEMS), nanoelectromechanical systems (NEMS), or micromachines.Subsequent to placing the Energy Source and component, a ReactiveMixture can be shaped by the mold part and polymerized to form theOphthalmic Lens.

In the following sections detailed descriptions of embodiments of theinvention will be given. The description of both preferred andalternative embodiments are exemplary embodiments only, and it isunderstood that to those skilled in the art that variations,modifications, and alterations may be apparent. It is therefore to beunderstood that said exemplary embodiments do not limit the scope of theunderlying invention.

GLOSSARY

In this description and claims directed to the presented invention,various terms may be used for which the following definitions willapply:

Back Curve Piece or Back Insert Piece: as used herein refers to a solidelement of a Rigid Insert which when assembled into the said insert willoccupy a location on the side of the lens that is on the back. In anOphthalmic Device, such a piece would be located on the side of theinsert that would be closer to the user's eye surface. In someembodiments, the back curve piece may contain and include a region inthe center of an Ophthalmic Device through which light may proceed intothe user's eye, which may be called an Optic Zone. In other embodiments,the piece may take an annular shape where it does not contain or includesome or all of the regions in an optic zone. In some embodiments of anophthalmic insert, there may be multiple back curve pieces and one ofthem may include the optic zone, while others may be annular or portionsof an annulus.

Component: as used herein refers to a device capable of drawingelectrical current from an Energy Source to perform one or more of achange of logical state or physical state.

Encapsulate: as used herein refers to creating a barrier to separate anentity, such as, for example, a Media Insert, from an environmentadjacent to the entity.

Encapsulant: as used herein refers to a layer formed surrounding anentity, such as, for example, a Media Insert, that creates a barrier toseparate the entity from an environment adjacent to the entity. Forexample, Encapsulants may be comprised of silicone hydrogels, such asEtafilcon, Galyfilcon, Narafilcon, and Senofilcon, or other hydrogelcontact lens material. In some embodiments, an Encapsulant may besemipermeable to contain specified substances within the entity andpreventing specified substances, such as, for example, water, fromentering the entity.

Energized: as used herein refers to the state of being able to supplyelectrical current to or to have electrical energy stored within.

Energy: as used herein refers to the capacity of a physical system to dowork. Many uses within this invention may relate to the said capacitybeing able to perform electrical actions in doing work.

Energy Source: as used herein refers to device capable of supplyingEnergy or placing a biomedical device in an Energized state.

Energy Harvesters: as used herein refers to device capable of extractingenergy from the environment and convert it to electrical energy.

Front Curve Piece or Front Insert Piece: as used herein refers to asolid element of a Rigid Insert, which when assembled into the saidinsert will occupy a location on the side of the lens that is on thefront. In an Ophthalmic Device, a Front Curve Piece would be located onthe side of the insert that would be further from the user's eyesurface. In some embodiments, the piece may contain and include a regionin the center of an Ophthalmic Device through which light may proceedinto the user's eye, which may be called an Optic Zone. In otherembodiments, the piece may take an annular shape where it does notcontain or include some or all of the regions in an optic zone. In someembodiments of an ophthalmic insert, there may be multiple front curvepieces and one of them may include the optic zone, while others may beannular or portions of an annulus.

Lens-forming mixture or Reactive Mixture or Reactive Monomer Mixture(RMM): as used herein refers to a monomer or prepolymer material thatcan be cured and cross-linked or cross-linked to form an OphthalmicLens. Various embodiments can include lens-forming mixtures with one ormore additives such as UV blockers, tints, photoinitiators or catalysts,and other additives one might desire in an Ophthalmic Lenses such as,contact or intraocular lenses.

Lens-forming Surface: refers to a surface that is used to mold a lens.In some embodiments, any such surface can have an optical qualitysurface finish, which indicates that it is sufficiently smooth andformed so that a lens surface fashioned by the polymerization of a lensforming material in contact with the molding surface is opticallyacceptable. Further, in some embodiments, the lens forming surface canhave a geometry that is necessary to impart to the lens surface thedesired optical characteristics, including without limitation,spherical, aspherical and cylinder power, wave front aberrationcorrection, corneal topography correction and the like as well as anycombinations thereof.

Lithium Ion Cell: refers to an electrochemical cell where Lithium ionsmove through the cell to generate electrical energy. Thiselectrochemical cell, typically called a battery, may be reenergized orrecharged in its typical forms.

Media Insert: as used herein refers to an encapsulated insert that willbe included in an energized Ophthalmic Device. The energization elementsand circuitry may be embedded in the Media Insert. The Media Insertdefines the primary purpose of the energized Ophthalmic Device. Forexample, in embodiments where the energized Ophthalmic Device allows theuser to adjust the optic power, the Media Insert may includeenergization elements that control a liquid meniscus portion in theOptical Zone. Alternatively, a Media Insert may be annular so that theOptical Zone is void of material. In such embodiments, the energizedfunction of the Lens may not be optic quality but may be, for example,monitoring glucose or administering medicine.

Mold: refers to a rigid or semi-rigid object that may be used to formlenses from uncured formulations. Some preferred molds include two moldparts forming a front curve Mold part and a back curve Mold part.

Ophthalmic Lens or Ophthalmic Device or Lens: as used herein refers toany device that resides in or on the eye. The device may provide opticalcorrection, may be cosmetic, or provide some functionality unrelated tooptic quality. For example, the term Lens may refer to a contact Lens,intraocular Lens, overlay Lens, ocular insert, optical insert, or othersimilar device through which vision is corrected or modified, or throughwhich eye physiology is cosmetically enhanced (e.g. iris color) withoutimpeding vision. Alternatively, Lens may refer to a device that may beplaced on the eye with a function other than vision correction, such as,for example, monitoring of a constituent of tear fluid or means ofadministering an active agent. In some embodiments, the preferred Lensesof the invention may be soft contact Lenses that are made from siliconeelastomers or hydrogels, which may include, for example, siliconehydrogels and fluorohydrogels.

Optic Zone: as used herein refers to an area of an Ophthalmic Lensthrough which a wearer of the Ophthalmic Lens sees.

Power: as used herein refers to work done or energy transferred per unitof time.

Rechargeable or Re-energizable: as used herein refers to a capability ofbeing restored to a state with higher capacity to do work. Many useswithin this invention may relate to the capability of being restoredwith the ability to flow electrical current at a certain rate for acertain, reestablished time period.

Reenergize or Recharge: To restore to a state with higher capacity to dowork. Many uses within this invention may relate to restoring a deviceto the capability to flow electrical current at a certain rate for aspecified, reestablished time period.

Released from a Mold: means that a lens is either completely separatedfrom the mold, or is only loosely attached so that it can be removedwith mild agitation or pushed off with a swab.

Rigid Insert: as used herein refers to an insert that maintains apredefined topography. When included in a Contact Lens, the Rigid Insertmay contribute to the functionality of the Lens. For example, varyingtopography of or densities within the Rigid Insert may define zones,which may correct vision in users with astigmatism.

Stabilizing Feature: as used herein refers to a physical characteristicthat stabilizes an Ophthalmic Device to a specific orientation on theeye, when the Ophthalmic Device is placed on the eye. In someembodiments, the Stabilizing Feature may add sufficient mass to ballastthe Ophthalmic Device. In some embodiments, the Stabilizing Feature mayalter the front curve surface, wherein the eyelid may catch theStabilizing Feature and the user may reorient the Lens by blinking. Suchembodiments may be enhanced by including Stabilizing Features that mayadd mass. In some exemplary embodiments, Stabilizing Features may be aseparate material from the encapsulating biocompatible material, may bean insert formed separately from the molding process, or may be includedin the Rigid Insert or Media Insert.

Stacked Integrated Component Devices or SIC Devices as used hereinrefers to the product of packaging technologies that can assemble thinlayers of substrates, which may contain electrical and electromechanicaldevices, into operative integrated devices by means of stacking at leasta portion of each layer upon each other. The layers may comprisecomponent devices of various types, materials, shapes, and sizes.Furthermore, the layers may be made of various device productiontechnologies to fit and assume various contours.

Three-dimensional Surface or Three-dimensional Substrate: as used hereinrefers to any surface or substrate that has been three-dimensionallyformed where the topography is designed for a specific purpose, incontrast to a planar surface.

Thermoforming

In a thermoforming process, a thin sheet of material is heated to atemperature where it becomes flexible or easily bent. The sheet ofmaterial is then bent or thermoformed to a predefined shape by a moldpiece. By pressing the sheet onto the mold and typically evacuating theair at the interface of the mold and sheet, the material is deformedinto a three-dimensional shape that similarly matches the mold piece.Upon cooling, an appropriate thin sheet material may maintain the threedimensional shape that it has been formed into.

Proceeding to FIG. 1, an exemplary apparatus 100 for thermoforming asheet may be found. The illustrated apparatus 100 is an exemplaryembodiment of an apparatus that may perform thermoforming, but otheralternative embodiments of an apparatus that performs thermoforming maybe consistent with the art herein. In some embodiments, a sheet 110 ofmaterial, which may be thermoformed, may have holes 111 punched into thesheet 110 so that the sheet may be fixedly held in place by otherportions of the apparatus.

The sheet 110 may be held in place by placement between a top holdingpiece 120 and a lower holding piece 130. Pins may align the holes 121 onthe top holding piece 120 and the holes 131 on the lower holding piece130 with the alignment holes 111 punched into the sheet 110. Once thesheet 110 is between the top holding piece 120 and the lower holdingpiece 130, the holding pieces 120 and 130 may be rigidly held together.In some embodiments, a locking feature such as, for example, a screw,may feed through a hole 121 in the top holding piece 120 at a locationexternal to the thin sheet 110. For example, a screw may feed into athreaded hole 132 to fixedly hold the sheet 110 in place. In otherembodiments, the thermoforming equipment may hold the sheet 110 in placewithout the use of screws or locking feature.

The held and aligned sheet 110 may be processed using numerous types ofequipment that may utilize alignment holes 122 and 132 for the alignmentof the held sheet 110. These processes may occur before or afterthermoforming, but in this exemplary embodiment, the held sheet 110 maybe processed for the step of thermoforming. In such embodiments, a pinthat protrudes through the lower holding piece 130 may locate thealignment features 122 and 132. The pin may extend above the lowerholding piece 130 to align the sheet 110 and the top holding piece 120and below the lower piece 130 to align the sheet with the moldingfeatures of the thermoforming apparatus 140. The pins below the lowerholding piece 130 may mate in an aligned fashion to alignment holes 141on the thermoforming apparatus 140.

In some embodiments, the molding apparatus 100 and the thin sheet 110may be warmed to an appropriate temperature to make the sheet pliable,and then pressure may be applied to push the thin sheet 110 that is heldbetween the top holding piece 120 and the lower holding piece 130 onto amolding piece 150. As pressure is applied, a vacuum may be drawn near orat the surface of the molding piece 150 through the molding apparatus100 through connection points 142 and 143. In some embodiments, thetemperature may be controlled at the molding piece 150. In alternateembodiments, a temperature-controlled fluid may be flowed through themolding apparatus 100 through connection points 142 and 143. In stillother embodiments, a power source, such as an electrical current, mayheat the forming mold through connection points 142 and 143. In otherembodiments, the entire environment of the sheet 110 and thermoformingapparatus 140 may be held at an appropriate temperature forthermoforming of the thin sheet 110 material.

When the pressure and vacuum are removed from holding the thin sheet 110onto the molding piece 150, the sheet 110 may be pulled clear of themolding piece 150. When the sheet 110 cools, it may reassume rigidity inthe three-dimensionally formed shape imparted to the sheet 110 by thethermoforming molding process.

Proceeding to FIG. 2, an exemplary progression 200 of a sheet processedto form an insert piece that may then be thermoformed is illustrated.This progression 200 is for exemplary purposes only, and othermodifications and sequences are within the scope of this invention.

The progression 200 may begin at step 210 wherein a thin sheet 211 ofthermoformable material may be provided. In some embodiments, forexample, the thin sheet 211 may be comprised of polycarbonate. Furtherexamples of thin sheet thermoforming material are included in Table 1.In some embodiments, at step 220, the sheet 211 may be processed to havealignment marks placed on it 221. For example, said alignment marks 221may be printed upon the sheet 211, punched into the sheet 211, or cutout from the sheet 211. Some embodiments may include holes 222 that arepunched into the sheet 211 to facilitate the holding of the sheet 211 ina thermoforming apparatus 100, such as, for example, in FIG. 1.

In some embodiments, at step 230, conductive traces 231 may be formedupon the sheet 211. These traces 231 may be formed by coating the sheet211 with films of conductive material followed by patterned removal ofregions of the conductive material to form traces 231. In alternateembodiments, the traces 231 may be printed upon the surface withconductive inks. Any method of forming conductive traces 231 upon a flatsheet may be consistent with the art herein.

In some embodiments, at step 240, the conductive traces 231 may becoated at least in part by an insulating material. A deposition ofinsulator may be important for some specific methods of manufacture,such as, for example, the formation of inserts for meniscus lensembodiments. In some embodiments, at step 250, regions of the insertpiece may be coated with a film to alter the hydrophobicity of thesurface. In the exemplary embodiment, at step 250, the entire sheet 211may be coated, but embodiments that coat only a portion of the sheet211, such as, for example, only the region that will become the insertpiece, are also within the scope of this invention. Step 250 may beconsistent with embodiments related to the formation of meniscus typeactive lenses. At step 260, the thin sheet 211 may be processed with athermoforming step creating a three-dimensional shape 261 to the surfaceof the thin film material.

In some embodiments, after 260, the thermoformed sheet 211 maysubsequently be processed to create isolated insert pieces. At step 270,a roughly circular-shaped insert piece may be formed by cutting out aspecified portion 271 of the thermoformed sheet. The method of cuttingmay include, for example, mechanical shearing, punching, or cutting withenergized beams, such as laser cutting, plasma cutting, chemicalreaction cutting, or high pressure fluid jet cutting.

The next step may depend on the preferred resulting insert pieceembodiment. At step 280, the insert piece may be removed from the sheet211 with a central optic portion. In alternative embodiments, at step290, the insert piece may be removed from the sheet 211 where thecentral optic portion 291 may also be removed creating an annular insertpiece. In this exemplary embodiment, the thermoformed sheet 211progresses from step 270 to either step 280 or step 290. In otherembodiments, step 280 may be an intermediate step between step 270 andstep 290. Other combinations and variations of this progression may beapparent to those ordinarily skilled in the art and are consideredwithin the scope of the art herein. Utilizing the techniques as havebeen discussed, more complicated insert pieces may be formed.

TABLE 1 Exemplary Thermoforming Materials Film Type AcrylonitrileButadiene Styrene Polycarbonate Polystyrene Polyvinyl Chloride Biaxiallyoriented polypropylene Polyethylene terephthalate (PET) Amorphous PETPET-glycol Orientated PET Biaxially oriented polypropylene Cyclic OlefinCopolymer

Proceeding to FIG. 3, an ophthalmic insert 300 from a thermoformed sheetis illustrated. In some embodiments, the ophthalmic insert 300 mayinclude numerous important features that result from thermoforming asheet into a three-dimensional piece. For example, in some embodiments,the optic zone 310 of an Ophthalmic Device formed with the insert 300may include an optically clear feature. In such embodiments, variousmaterial choices and thermoforming equipment settings may address theoptical clarity of a thermoformed surface.

Conductive traces 320, 330, 340, 370, and 380 may be added to the thinfilm surface before thermoforming or to the three dimensional shapeafter thermoforming. In some embodiments, the surface may include one orboth of isolated conductive traces 340 and 370 or electrically connectedtraces 330 and 380 with a connection point at 320. The placement of thetraces 320, 330, 340, 370, and 380 on the ophthalmic insert 300 is forexemplary purposes only, and other configurations may be appropriate insome alternative embodiments. The arrangement may be useful in formingan energized insert with two electrochemical battery cells connected ina series fashion. The resulting energization element may have connectionpoints 350 and 360. Components capable of drawing an electrical currentfrom an energization element may be attached, for example, to theconnection points 350 and 360 or, in other embodiments, other locationson the depicted ophthalmic insert embodiment.

Alignment Aspects of Thermoformed Inserts

For complex insert components including three-dimensional shapes,conductive traces, and other components attached or integrated to thethree-dimensionally shaped inserts, the location of the features and thethree-dimensional shapes both relatively and globally to otherOphthalmic Lens aspects may be significant. Alignment features on theinsert piece may be useful in precision placement of the components.There may be various designs consistent with alignment needs includingcrosses, verniers, lines, and similar such features. The equipment thatprocesses the thin film substrate may utilize these features to move thesheet and attached or holding hardware to an internal alignment locationwithin its operating space. In some embodiments, the alignment featuremay be a portion of the thin film substrate that may be cut away duringprocessing.

Proceeding to FIG. 4, strategies or features that may create secondaryalignment features during the processing to cut out the insert piece areillustrated. A thermoformed, three dimensionally shaped insert piece 400that has been cut out from the thin sheet may have notches 401 and 402cut out. Different embodiments may include notches of varying shapeincluding, for example, a v-shaped notch, a circular-shaped notch, and asquare-shaped notch. Notches 401 and 402 may be located in variouslocations on the insert piece 400, including, for example, at antipodallocations. The notches 401 and 402 may serve a variety of alignmentfunctions. For example, the notches 401 and 402 may provide therotational alignment of the piece, whereas, in some other embodiments,alignment features 401 and 402 on the insert piece 400 may create thealignment in the translational axes of the paper.

In other embodiments, the insert piece 450 may have grooves 451 and 452.These grooves 451 and 452, or in some embodiments cut outs, may functionsimilarly to the notches 401 and 402, wherein the grooves 451 and 452assist in alignment during the process of removing the insert piece 450from a thin sheet, as shown in FIG. 2. In some embodiments, particularlywhere the insert is comprised of multiple pieces, grooves 451 and 452may provide a locking function. Said embodiments may include anotherinsert piece, not shown, with protrusions that may fit into the grooves451 and 452.

In some embodiments of an insert piece 480, there may be more than onealignment features or notches. For example, some insert pieces 480 mayhave notches 481 and 482 for an apparatus to place the piece withprecision and may include grooves 483 and 484 to ensure proper alignmentwith another piece. The insert pieces may also include flat featuresthat act similarly to the notches by preventing unwanted rotation of theinsert piece.

There may be numerous manners that processing equipment may utilizenotches of the type depicted. For example, a working surface of a pieceof equipment may have alignment pins temporarily or permanently locatedon a surface. By moving the insert piece such that its notches locateupon the pins, the insert piece may be simultaneously held in place andlocated in the translational plane. The rotational orientation in suchan embodiment may be limited to two acceptable rotational orientationsthat are 180 degrees apart. Alternatively, a three-dimensionally formedinsert piece may inherently be limited in orientations, necessitatingfewer alignment features for precise placement.

Proceeding to FIG. 5, an embodiment of an Ophthalmic Lens 500 with athermoformed Rigid Insert 570 is illustrated. In some embodiments, athree-dimensionally formed insert piece 520 may form a front insertpiece of a Rigid Insert 570, and a second three-dimensionally formedinsert piece 550 may form a back insert piece of a Rigid Insert 570. Thefront insert piece 520 may have alignment features 521 and 522 that fitwith the alignment features 551 and 552 of the back insert piece 550.

In a cross-sectional view, the front insert piece 530 may be combinedwith the back insert piece 560 to form a Rigid Insert 570. The insertpieces 530 and 560 may be three-dimensionally formed to create a sealedportion. In some embodiments, for example, the sealed portion maycontain a liquid meniscus in electrical communication with energizationelements, which may allow for a variable optic. The Rigid Insert 570 maybe encapsulated in an Ophthalmic Lens 500. In some embodiments, theencapsulant 501 may be a biocompatible polymerized material such as asilicone hydrogel, including, for example, Etafilcon, Narafilcon,Galyfilcon, and Senofilcon.

The alignment features 521, 522, 551, and 552 may allow the two insertpieces 520 and 550 to lock into place without direct force to the OpticZone portion or the component. This may allow for more delicate, butprecise, assembly of a Rigid Insert 570. For example, a liquid meniscusmay be susceptible to damage caused by pressure or heat. In someembodiments, the front piece insert 520 may be locked into the backpiece insert 550, and the locking between the alignment features 521,522, 551, and 552 may maintain the positions of the two pieces 520 and550. The Rigid Insert 570 may be further secured by applying focusedpressure or heat to more robust portions of the insert 570.

Rigid Inserts may also be useful for embodiments with annular shapes.There may be numerous uses for annular inserts in Ophthalmic Lensesincluding embodiments that may sense the ophthalmic environment that thelens sits in, such as a means for glucose monitoring. Rigid Inserts mayalso include a printed patterns or Stabilizing Features in the non-OpticZone portion.

In such embodiments, an active meniscus-based lens may be containedwithin the insert. For example, the Optic Zone may contain at least twoimmiscible fluids that form an interface between them that may act as afocal element. Various energization elements may be included in regionsoutside the Optic Zone of the insert. The energization elements mayinclude, for example, integrated circuits, passive electroniccomponents, energization elements, and activation elements that maycontrol the nature of the meniscus based lens.

Proceeding to FIG. 6, an exemplary front insert piece 610 and backinsert piece 630 are illustrated with the Media Insert 660 that mayresult in the combination of the two pieces 610 and 630. The frontinsert piece 610 may be thermoformed to include recesses 611 and 612 asalignment features for energization elements 662 and a controlling load661 in the Media Insert 660. Said recesses 611 and 612 may provideadditional protection of the electrical components 661 and 662 withinthe Media Insert 660. The back insert piece 630 may contain guidelines633 for the conductive traces 663 that may interconnect the electricalcomponents 661 and 662. Alternatively, in some embodiments, theconductive traces 663 may be directly applied during the thermoformingprocess, before or after the insert piece 630 has been removed from thesurrounding sheet, as in FIG. 2.

In some embodiments, the Media Insert 660 may be included in anOphthalmic Device 680, which may comprise a polymeric biocompatiblematerial. The Ophthalmic Device 680 may include a rigid center, softskirt design wherein a central rigid optical element comprises the MediaInsert 660. In some specific embodiments, the Media Insert 660 may be indirect contact with the atmosphere and the corneal surface on respectiveanterior and posterior surfaces, or alternatively, the Media Insert 660may be encapsulated in the Ophthalmic Device 680. The periphery orencapsulant 681 of the Ophthalmic Lens 680 may be a soft skirt material,including, for example, a hydrogel material.

Proceeding to FIG. 7, an alternate embodiment of an Ophthalmic Lens 700with a Rigid Insert 770 is illustrated. In some embodiments, the frontinsert piece 720 may be a different size than the back insert piece 750.Said embodiments also allow for thermoformed alignment features 721,722, 751, and 752, wherein alignment features 721 and 722 on the frontinsert piece 720 may fit to the alignment features 751 and 752 on theback insert piece 750.

In a cross-sectional view, the Rigid Insert 770 may bethree-dimensionally formed to allow for a passive optical function, suchas, for example, a lenslet 771. A lenslet 771 may be located at thecenter of the Optic Zone of an Ophthalmic Lens 700. In this exemplaryembodiment, the lenslet 771 is a concave device that may be filled witha material in a gaseous, liquid or solid state (including gelled solids)where the index of refraction may be different from the surroundingOphthalmic Lens material 701. In some embodiments, the lenslet 771 mayprovide a focal altering characteristic. For example, the lenslet 771may provide focusing and magnification of an object located relativelyclose to the Ophthalmic Lens.

In forming the Rigid Insert 770, there may be numerous considerationsfor the processing. The lenslet 771 in some embodiments may be filledwith a gaseous material. Since the pressure in the lenslet 771 maychange with the temperature of processing and the temperature of use, itmay be important to control the temperature of all processing stepsafter the multiple pieces are assembled and sealed into an insert. Forexample, maintaining the temperature around a set point of roughly 35degrees Celsius in some embodiments may mitigate changes caused byfilling the insert with liquids and or gelled or partially gelled solidswith different index of refraction from either or both the thermoformingfilm material and Ophthalmic Lens encapsulating material. Alternatively,the lenslet 771 may hold an encapsulated lenslet material 772. In someembodiments, the lenslet material 772 may be coated, with parylene, forexample, to isolate the lenslet material 772 from the surroundingmaterial.

Functional Aspects of Thermoformed Inserts

Proceeding to FIG. 8, examples of embodiments where thermoforming mayadd functionality to the insert piece are illustrated. An insert piece800 may provide a means to deliver an active agent, such as medicine.Guidelines 801-803 may be thermoformed on the insert piece 800, or insome embodiments, the active agent may directly applied duringthermoforming. Adding an active agent to an insert piece 800 may allowfor controlled administering of a drug to the body through the eye.

In some embodiments, an insert piece 800 may be an annular shape with acentral circular shape, which may have its center collocated with theexternal approximately circular shape removed. An annular shape may beappropriate where the function of the Ophthalmic Lens with an insertpiece 800 may not be related to optical properties, such as, forexample, where the purpose is to passively administer an active agentdeposited on guidelines 801-803. The material removed from the internalregions may in practice assume a great diversity of shapes and alsoinvolve the nature of the three-dimensional features that may bethermoformed into the film. For example, the cutting process may removethose features with a height of deformation above a certain level.

In some embodiments, thermoforming may add colored design to the insertpiece 820, which may give an Ophthalmic Lens a cosmetic function. Thepattern 821 may have been applied before or after thermoforming and maybe located on one or both of the major surfaces of a thermoformedinsert. A printed pattern 821 may be located outside of the Optic Zoneof the Ophthalmic Lens. Therefore, a printed pattern 821 may be includedin embodiments where the Ophthalmic Lens has functions in addition to acosmetic feature. For example, a printed pattern 821 may be included ona multi-piece Rigid Insert 570, such as shown in FIG. 5. In alternativeembodiments, a printed pattern 821 may be included in annular insertpieces, such as, for example, where the function of the Ophthalmic Lensor the function of the Rigid Insert is not related to an opticalquality. In some specific embodiments, a printed pattern 821 may beincluded in insert pieces 800 to mask active agent guidelines 801-803.

Alternatively, polarization features 851 may be thermoformed onto aninsert piece 850. In some embodiments, such features 851 may be impartedto insert pieces 850 through properties of thin film starting materials.The innate polarizing properties of the starting material may beenhanced by thermoforming additional polarization features 851.Alternatively, the thermoforming process may be sufficient to impart thepolarization features 851. The inclusion of polarizing features 851 toan insert piece 850 may add functionality in some embodiments that maycontain passive, nonenergized inserts.

There are four major techniques for polarizing light through atransmissible material including wire grids, dichroic materials as iscommonly employed in “polaroid filters”, employment of Brewster's anglesplates, and employment of birefringent or biaxial materials. Thepolarization function may be developed in an Ophthalmic Lens through asingle technique or by a combination of techniques. For example, in someembodiments, the polarizing features 851 of an insert piece 850 mayinclude wire grids and dichroic materials.

In some embodiments, the structure of the insert itself or layers placedupon the insert piece may polarize light that transmits through theophthalmic insert optic zone. For example, the thermoforming thin filmmaterial that is used to form the insert may be constructed in amultilayer fashion, such as by stacking layers to form the structuralfunction of the insert piece 850 and to polarize light. In someembodiments, the sheet of material from which the insert piece 850 isremoved may be a sheet of thin metallic or conductive filaments or linesdeployed in a parallel fashion to form a wire grid.

Alternatively, a film of dichroic materials may have polarizingproperties imparted to it. Some embodiments may include layers of films,each contributing to the polarizing features 851. For example, the topand bottom films may act to protect the internal polarizing film, andthe protecting layers may be three-dimensionally formed through thethermoforming process. A polarized insert piece 850 may also haveprinted patterns 821 included in the portion outside of the Optic Zone.

In other embodiments, a Rigid Insert may be comprised of insert pieceswith polarizing features that, when layered in the Rigid Insert, maycreate a complex polarization element. For example, the polarizingfeatures may be enhanced by thermoformed topography of an insert piece.

Some embodiments may include an insert piece 880 with a tinting 881 inthe Optic Zone. In some embodiments, the color tint may be an innateproperty of the thin film material used as a starting material. In otherembodiments, the coloring property may be added to the thin filmmaterial by depositions, applications, or other means of imparting acolor to the thin film surface or bulk. A color tinting 881 may providea variety of functions in an Ophthalmic Lens. For example, the tinting881 may be useful in excluding or attenuating wavelengths of light asmay be the function of shading ambient sunlight.

Alternatively, information may be displayed in different wavelengthregimes, where an Ophthalmic Lens with appropriate filter aspects mayuse or exclude the information. The tinting 881 may provide safetyfunctions where the tinting may block certain wavelengths therebyshielding or partially shielding the effect of intense radiation sourcessuch as, for example, lasers or welding arcs. In some embodiments, thetinting 881 may address medical conditions in some users, who maybenefit from either passing or rejecting certain wavelengths fromentering the user's eye. Numerous filtering or band pass functions maybe imparted to Ophthalmic Lenses by their inclusion into insert pieces880, and the process of thermoforming flat sheets of material mayenhance methods and process related to such embodiments.

Proceeding to FIG. 9, an exemplary embodiment of a left Lens 910 and aright Lens 960 with insert pieces 900 and 950 that have beenthermoformed to include polarization features 901 and 951 isillustrated. Together, the inserts may act as a set of functionalOphthalmic Lenses. Polarizing features 901 and 951 may be incorporatedinto insert pieces 900 and 950 in the Optic Zone. Alignment features,such as, for example, those included in the exemplary embodiments inFIG. 4, may allow for precise control of the differing polarizingorientations of the right lens 910 and the left lens 960.

For example, when the polarizing insert piece 900 and 950 is assembledinto an Ophthalmic Lens 910 and 960, the insert piece 900 and 950 may bepositioned with alignment features into a cavity formed between a frontcurve Mold and a back curve Mold. The insert piece 900 and 950 may beencapsulated by filling the area between the Mold Pieces with ReactiveMonomer Mixture and then polymerizing the RMM. Numerous Reactive MonomerMixtures may be consistent with the formation of molded OphthalmicDevices, including, for example, those capable of forming hydrogellenses, such as silicone hydrogel.

In some embodiments, during the molding process, the molds may includecapability of forming Stabilizing Features 912, 913, 962, and 963 intothe Ophthalmic Devices. These stabilization zones may be thicker regionsof gelled polymer material in the regions depicted. The gelled polymermaterial may be added to the Molds prior to encapsulation, or, in otherembodiments, may be injected into the skirt 911 and 961 afterpolymerization.

Alternatively, Stabilizing Features 902, 903, 952, and 953 may bethermoformed into the insert pieces 900 and 950. In some suchembodiments, as seen in cross-section, the Stabilizing Features 922 and972 may not affect the surface of the Ophthalmic Lens 920 and 970.Whereas, in other embodiments, not shown, the Stabilizing Features mayaffect the surface topography of the Ophthalmic Lens.

Thermoforming allows for more complex three-dimensionally formed insertpieces, as seen cross section, 921 and 971. Therefore, the insert piece921 and 971 may be formed from a single sheet, as seen in FIG. 2, or,alternatively, the Stabilizing Features 922 and 972 may be attachedafter the insert piece 921 and 971 has been removed from the sheet. Theattachment may utilize thermoforming techniques or any other means ofattachment, such as, for example, the use of adhesives.

The extra mass and, where the Stabilizing Features alter the surfacetopography of the Ophthalmic Lens, the interaction of the StabilizingFeatures with a user's eyelids may hold the lenses in a rotational andtranslational orientation relative to the user's eye. Said StabilizingFeatures 912, 913, 962, and 963 may allow for Lenses 910 and 960 thathave similar polarizing orientation, such as, for example, where theLenses 910 and 960 shield the eye from reflected sunlight.Alternatively, as shown, a different orientation of the polarizingelements 901 and 951 may allow for differential communication ofinformation to each eye, which may provide numerous functions, includingThree-dimensional Perception of stereoscopic media. As with otherembodiments, these types of embodiments may also include printedpatterns in the portion 911 and 961 outside the Optic Zone.

Materials for Insert Based Ophthalmic Lenses

In some embodiments, a lens type can be a lens that includes a siliconecontaining component. A “silicone-containing component” is one thatcontains at least one [—Si—O—] unit in a monomer, macromer, orprepolymer. Preferably, the total Si and attached O are present in thesilicone-containing component in an amount greater than about 20 weightpercent, and more preferably greater than 30 weight percent of the totalmolecular weight of the silicone-containing component. Usefulsilicone-containing components preferably comprise polymerizablefunctional groups such as acrylate, methacrylate, acrylamide,methacrylamide, vinyl, N-vinyl lactam, N-vinylamide, and styrylfunctional groups.

In some embodiments, the Ophthalmic Lens skirt, which sometimes may becalled an insert encapsulating layer, that surrounds the insert may becomprised of standard hydrogel lens formulations. Exemplary materialswith characteristics that may provide an acceptable match to numerousinsert materials may include the Narafilcon family; including NarafilconA and Narafilcon B. Alternatively, the Etafilcon family; includingEtafilcon A may represent good exemplary material choices. A moretechnically inclusive discussion follows on the nature of materialsconsistent with the art herein; but it may be clear that any materialwhich may form an acceptable enclosure or partial enclosure of thesealed and encapsulated inserts are consistent and included.

Suitable silicone containing components include compounds of Formula I

where:

R¹ is independently selected from monovalent reactive groups, monovalentalkyl groups, or monovalent aryl groups, any of the foregoing which mayfurther comprise functionality selected from hydroxy, amino, oxa,carboxy, alkyl carboxy, alkoxy, amido, carbamate, carbonate, halogen orcombinations thereof; and monovalent siloxane chains comprising 1-100Si—O repeat units which may further comprise functionality selected fromalkyl, hydroxy, amino, oxa, carboxy, alkyl carboxy, alkoxy, amido,carbamate, halogen or combinations thereof;

where b=0 to 500, where it is understood that when b is other than 0, bis a distribution having a mode equal to a stated value;

wherein at least one R¹ comprises a monovalent reactive group, and insome embodiments between one and 3 R¹ comprise monovalent reactivegroups.

As used herein “monovalent reactive groups” are groups that can undergofree radical and/or cationic polymerization. Non-limiting examples offree radical reactive groups include (meth)acrylates, styryls, vinyls,vinyl ethers, C₁₋₆alkyl(meth)acrylates, (meth)acrylamides,C₁₋₆alkyl(meth)acrylamides, N-vinyllactams, N-vinylamides,C₂₋₁₂alkenyls, C₂₋₁₂alkenylphenyls, C₂₋₁₂alkenylnaphthyls,C₂₋₆alkenylphenylC₁₋₆alkyls, O-vinylcarbamates and O-vinylcarbonates.Non-limiting examples of cationic reactive groups include vinyl ethersor epoxide groups and mixtures thereof. In one embodiment the freeradical reactive groups comprises (meth)acrylate, acryloxy,(meth)acrylamide, and mixtures thereof.

Suitable monovalent alkyl and aryl groups include unsubstitutedmonovalent C₁ to C₁₆alkyl groups, C₆-C₁₄ aryl groups, such assubstituted and unsubstituted methyl, ethyl, propyl, butyl,2-hydroxypropyl, propoxypropyl, polyethyleneoxypropyl, combinationsthereof and the like.

In one embodiment b is zero, one R¹ is a monovalent reactive group, andat least 3 R¹ are selected from monovalent alkyl groups having one to 16carbon atoms, and in another embodiment from monovalent alkyl groupshaving one to 6 carbon atoms. Non-limiting examples of siliconecomponents of this embodiment include2-methyl-2-hydroxy-3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxanyl]propoxy]propylester (“SiGMA”),2-hydroxy-3-methacryloxypropyloxypropyl-tris(trimethylsiloxy)silane,3-methacryloxypropyltris(trimethylsiloxy)silane (“TRIS”),3-methacryloxypropylbis(trimethylsiloxy)methylsilane and3-methacryloxypropylpentamethyl disiloxane.

In another embodiment, b is 2 to 20, 3 to 15 or in some embodiments 3 to10; at least one terminal R¹ comprises a monovalent reactive group andthe remaining R¹ are selected from monovalent alkyl groups having 1 to16 carbon atoms, and in another embodiment from monovalent alkyl groupshaving 1 to 6 carbon atoms. In yet another embodiment, b is 3 to 15, oneterminal R¹ comprises a monovalent reactive group, the other terminal R¹comprises a monovalent alkyl group having 1 to 6 carbon atoms and theremaining R¹ comprise monovalent alkyl group having 1 to 3 carbon atoms.Non-limiting examples of silicone components of this embodiment include(mono-(2-hydroxy-3-methacryloxypropyl)-propyl ether terminatedpolydimethylsiloxane (400-1000 MW)) (“OH-mPDMS”), monomethacryloxypropylterminated mono-n-butyl terminated polydimethylsiloxanes (800-1000 MW),(“mPDMS”).

In another embodiment b is 5 to 400 or from 10 to 300, both terminal R¹comprise monovalent reactive groups and the remaining R¹ areindependently selected from monovalent alkyl groups having 1 to 18carbon atoms which may have ether linkages between carbon atoms and mayfurther comprise halogen.

In one embodiment, where a silicone hydrogel lens is desired, the lensof the present invention will be made from a Reactive Mixture comprisingat least about 20 and preferably between about 20 and 70% wt siliconecontaining components based on total weight of reactive monomercomponents from which the polymer is made.

In another embodiment, one to four R¹ comprises a vinyl carbonate orcarbamate of the formula:

wherein: Y denotes O—, S— or NH—;

R denotes, hydrogen or methyl; and q is 0 or 1.

The silicone-containing vinyl carbonate or vinyl carbamate monomersspecifically include:1,3-bis[4-(vinyloxycarbonyloxy)but-1-yl]tetramethyl-disiloxane;3-(vinyloxycarbonylthio)propyl-[tris(trimethylsiloxy)silane];3-[tris(trimethylsiloxy)silyl]propyl allyl carbamate;3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate;trimethylsilylethyl vinyl carbonate; trimethylsilylmethyl vinylcarbonate, and

Where biomedical devices with modulus below about 200 are desired, onlyone R¹ shall comprise a monovalent reactive group and no more than twoof the remaining R¹ groups will comprise monovalent siloxane groups.

Another class of silicone-containing components includes polyurethanemacromers of the following formulae:(*D*A*D*G)_(a)*D*D*E¹;E(*D*G*D*A)_(a)*D*G*D*E¹ or;E(*D*A*D*G)_(a)*D*A*D*E¹  Formulae IV-VIwherein:

D denotes an alkyl diradical, an alkyl cycloalkyl diradical, acycloalkyl diradical, an aryl diradical or an alkylaryl diradical having6 to 30 carbon atoms,

G denotes an alkyl diradical, a cycloalkyl diradical, an alkylcycloalkyl diradical, an aryl diradical or an alkylaryl diradical having1 to 40 carbon atoms and which may contain ether, thio or amine linkagesin the main chain;

* denotes a urethane or ureido linkage;

_(a) is at least 1;

A denotes a divalent polymeric radical of formula:

R¹¹ independently denotes an alkyl or fluoro-substituted alkyl grouphaving 1 to 10 carbon atoms which may contain ether linkages betweencarbon atoms; y is at least 1; and p provides a moiety weight of 400 to10,000; each of E and E¹ independently denotes a polymerizableunsaturated organic radical represented by formula:

wherein: R¹² is hydrogen or methyl; R¹³ is hydrogen, an alkyl radicalhaving 1 to 6 carbon atoms, or a —CO—Y—R¹⁵ radical wherein Y is —O—,Y—S— or —NH—; R¹⁴ is a divalent radical having 1 to 12 carbon atoms; Xdenotes —CO— or —OCO—; Z denotes —O— or —NH—; Ar denotes an aromaticradical having 6 to 30 carbon atoms; w is 0 to 6; x is 0 or 1; y is 0 or1; and z is 0 or 1.

A preferred silicone-containing component is a polyurethane macromerrepresented by the following formula:

Formula IX (the full structure may be understood by joiningcorresponding asterisk regions, * to *, ** to **)

wherein R¹⁶ is a diradical of a diisocyanate after removal of theisocyanate group, such as the diradical of isophorone diisocyanate.Another suitable silicone containing macromer is compound of formula X(in which x+y is a number in the range of 10 to 30) formed by thereaction of fluoroether, hydroxy-terminated polydimethylsiloxane,isophorone diisocyanate and isocyanatoethylmethacrylate.Formula X (the full structure may be understood by joining correspondingasterisk regions, * to *)

Other silicone containing components suitable for use in this inventioninclude macromers containing polysiloxane, polyalkylene ether,diisocyanate, polyfluorinated hydrocarbon, polyfluorinated ether andpolysaccharide groups; polysiloxanes with a polar fluorinated graft orside group having a hydrogen atom attached to a terminaldifluoro-substituted carbon atom; hydrophilic siloxanyl methacrylatescontaining ether and siloxanyl linkanges and crosslinkable monomerscontaining polyether and polysiloxanyl groups. Any of the foregoingpolysiloxanes can also be used as the silicone-containing component inthis invention.

Methods

The following method steps are provided as examples of processes thatmay be implemented according to some aspects of the present invention.It should be understood that the order in which the method steps arepresented is not meant to be limiting and other orders may be used toimplement the invention. In addition, not all of the steps are requiredto implement the present invention and additional steps may be includedin various embodiments of the present invention.

Referring now to FIG. 10, item 1000, a flowchart illustrates exemplarysteps that may be used to implement the present invention. At 1001, aflat substrate typically in the form of a sheet of material may havealignment features imparted to it. These features may be stamped or cutout shapes made into the sheet or deformed regions as a stamp mayprovide without cutting material. In other embodiments, an alignmentfeature may be printed upon the sheet. In some embodiments, the surfaceor bulk of the sheet may have altered coloration by various processesincluding thermal treatments. The shapes may include crosses, verniers,multidirectional lines or the like, which when observed by a processingtool may allow for the unambiguous translational and rotationalalignment of the piece. In addition, in some embodiments, holdingfeatures that may fixedly lock into place the substrate duringprocessing may be formed. These features may be cut out features ofvarious shapes that allow locating pins or components to feed throughthe substrate sheet in defined manners.

At 1002, in some embodiments, a Rigid Insert may include electricaltraces that may be formed upon the flat substrate in defined locationsrelative to the alignment features. The methods of forming theseinterconnect features may include, for example, deposition and patternedetching; direct writing of interconnect features, such a, withlaser-induced chemical vapor deposition; printing upon the substrate,such as with conductive ink printing; or pattered by the screeneddeposition of conductive material. In a specialized version of theprocessing, in some embodiments, the definition of alignment featuresand the placement of interconnect features may be performedsimultaneously in the same processing steps.

At 1003 in some embodiments, dielectric or insulating films may beformed in selected regions. These may cover and insulate the traces inthe regions of deposition. The dielectric or insulating films may bedeposited in blanket fashion followed by a patterned etching process,may be printed from an insulating ink material, or may be regionallydeposited by a screened deposition process.

At 1004 in some embodiments, and particularly in those embodiments thatform an electro-wetting based meniscus lens active optic element, a filmmay be regionally applied to alter the hydrophobicity of the appliedsubstrate and substrate features surface. The method of application mayinclude techniques as may be utilized for steps 1002 and 1003.

At 1005, the thin sheet with any applied films may next be subjected toa thermoforming process. In many embodiments the alignment featuresformed in steps 1001 or 1002 may be used to align the thin filmsubstrate with the correct location relative to a mold piece upon whichthe substrate may be thermoformed into a desired three dimensionalshape. In some embodiments, the processing may occur for a singlemolding feature at a time, in others multiple thermoforming heads may besimultaneous applied to substrate material to create a number ofthermoformed features.

At 1006, the thermoformed substrate may have insert pieces cut from it.The alignment features formed at step 1001 or 1002 may be useful toensure the correct alignment of the cutting process to the variousaligned features of and on the three dimensionally formed substratepiece.

The cutting process may be performed by mechanical sheering, as mayoccur with a sharp stamping process or other sheering process, and mayintroduce into the singulated or cut-out insert piece other alignmentfeatures to simultaneously register alignment even if the previousalignment features are removed from the insert piece by the cuttingoperation. These new alignment features may include, for example,notches, slots, rounds, and flats, or various combinations of these. Theresulting insert piece may comprise the insert in cases of a singlepiece insert. In multi-piece Rigid Inserts, at 1007, steps at 1001-1006may be repeated to form at least a second insert piece. In suchembodiments, at 1007, the resulting insert piece may be combined withother three-dimensionally shaped features or with other insert pieces.When the insert piece is sealed, joined, or connected to the otherthree-dimensional insert pieces, together they may form an ophthalmicinsert. In some such embodiments, the step at 1008 may utilize athermoforming process, for example, where multiple pieces areconstructed in concert or where the functional features are notsusceptible to thermoforming temperatures.

At 1008, the resulting ophthalmic insert may be encapsulated byOphthalmic Lens-forming materials to form an Ophthalmic Device. In someembodiments, the Ophthalmic Lens may be formed by placing a formedinsert between two mold parts and by reacting a lens forming mixturemolding the insert piece to be within the Ophthalmic Lens. The moldingprocess may also occur in multiple steps where a thin layer of ReactiveMixture may be initially formed on a mold surface followed by theplacement of the insert and fixed by reacting the Reactive Mixture. Thecombination of a first Ophthalmic Lens layer and the insert is thenformed with additional Reactive Mixture between the molds into anOphthalmic Lens. The various materials that have been discussed may beused alone or in combination to form an Ophthalmic Device that includesan embedded insert, which may include three-dimensional pieces that havebeen formed by thermoforming

Although the invention may be used to provide inserts containing hard orsoft contact lenses made of any known lens material, or materialsuitable for manufacturing such lenses, preferably, the lenses of theinvention are soft contact lenses having water contents of about 0 toabout 90 percent. More preferably, the lenses are made of monomerscontaining hydroxy groups, carboxyl groups, or both or be made fromsilicone-containing polymers, such as siloxanes, hydrogels, siliconehydrogels, and combinations thereof. Material useful for forming thelenses of the invention may be made by reacting blends of macromers,monomers, and combinations thereof along with additives such aspolymerization initiators. Suitable materials include, withoutlimitation, silicone hydrogels made from silicone macromers andhydrophilic monomers.

CONCLUSION

The present invention, as described above and as further defined by theclaims below, provides methods for creating single-piece or multi-pieceRigid Inserts that may be included in an Ophthalmic Lenses or maycomprise the Ophthalmic Lens, wherein the Rigid Insert may be formedthrough the processing of thin sheet material by thermoforming. Singlepiece annular ophthalmic inserts may perform the function of providing atemplate for printed patterns to be included in Ophthalmic Lenses.Single piece full ophthalmic inserts may perform the function ofpolarizing light or filtering light based on the properties of materialsused to form the insert. The present invention also includes apparatusfor implementing such methods, as well as Ophthalmic Lenses and insertsformed with the Rigid Insert pieces that have been thermoformed.

The invention claimed is:
 1. An Ophthalmic Lens with a thermoformedinsert device, the Ophthalmic Lens comprising: a thermoformed insertdevice, wherein the thermoformed insert device comprises a first insertpiece, wherein the first insert piece is a thermoformed material of athree-dimensional shape; and a hydrogel encapsulant around thethermoformed insert device; wherein the thermoformed insert devicecomprises a plurality of layers of material; and wherein a layer ofmaterial alters the hydrophobicity of the surface of the first insertpiece.
 2. An Ophthalmic Lens with a thermoformed insert device, theOphthalmic Lens comprising: a thermoformed insert device, wherein thethermoformed insert device comprises a first insert piece, wherein thefirst insert piece is a thermoformed material of a three-dimensionalshape; and a hydrogel encapsulant around the thermoformed insert device;wherein the thermoformed insert device comprises a plurality of layersof material; wherein a polarizing layer is located between a second andthird layer adjacent to a first layer and wherein the second and thirdlayer orient the polarizing layer; and wherein the polarizing layer isaligned with respect to an alignment feature located within the body ofthe first insert piece.
 3. An Ophthalmic Lens with a thermoformed insertdevice, the Ophthalmic Lens comprising: a thermoformed insert device,wherein the thermoformed insert device comprises a first insert piece,wherein the first insert piece is a thermoformed material of athree-dimensional shape; a hydrogel encapsulant around the thermoformedinsert device; and a second insert piece, wherein the second insertpiece is a thermoformed material of a three-dimensional shape, wherein acavity is defined in a region between the first insert piece and thesecond insert piece.
 4. The Ophthalmic Lens of claim 3, wherein thethermoformed insert device further comprises: a first alignment featurelocated on the first insert piece; a second alignment feature located onthe second insert piece.
 5. The Ophthalmic Lens of claim 4, wherein thefirst alignment feature interlocks with the second alignment feature. 6.The Ophthalmic Lens of claim 3, wherein the thermoformed insert devicefurther comprises: a sealing layer between the first insert piece andsecond insert piece that seals the first insert piece and second insertpiece together along at least portions of their surfaces.
 7. TheOphthalmic Lens of claim 3, wherein the thermoformed insert devicefurther comprises: a meniscus lens active optic element, wherein themeniscus lens active optic element is located between the first insertpiece and the second insert piece.